FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2211159
·
Received August 8, 2011
Report
- Report Number
- 1720753-2011-20825
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE END STOPS FOR THE IRIS APERTURE WERE CALIBRATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT INTERMITTENTLY THE SYSTEM DISPLAYED A POTENTIOMETER IRIS CONTROL ERROR MESSAGE AND THE COLLIMATORS WERE NOT WORKING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |